Approval Order StatementThe device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2) recurrnet, poolrly tolerated, sustained ventricular tachyarrhythmia.